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Non Hodgkin LymphomaCONVENIENCENCT03619993

Patient Preference for Pegfilgrastim (Neulasta®) Application Forms

A study testing On-body injector and Pre-filled syringe in people with Non Hodgkin Lymphoma and Breast Cancer, run by iOMEDICO AG at 48 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma, Breast Cancer
What is being tested?
On-body injector and Pre-filled syringe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
48 sitesGermany
Study dates
25 Jun 2018to 10 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with early breast cancer planned to receive 3 weekly or dose-dense anthracycline/cyclophosphamide combination or 3 weekly taxane containing chemotherapy regimen or patients with NHL planned to receive R-CHOP-14 or R-CHOP-21 immunochemotherapy as 1st-line treatment with the indication for G-CSF prophylaxis with pegfilgrastim for the prevention of FN and reduction in CIN duration. Patients have to be included before start of their (immuno-) chemotherapy.
  • ECOG (Eastern Cooperative Oncology Group) performance status 0, 1 or 2
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1.5 x 109/L
  • Ability to read and understand German
  • Signed informed consent

Who cannot join

  • Hypersensitivity to the active substance or to any of the excipients
  • Subject is currently enrolled or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving investigational agent(s)
  • Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment
  • Prior bone marrow or stem cell transplantion
  • Subject of child-bearing potential is evidently pregnant (e.g. positive HCG (Human Chorionic Gonadotropin) test) or is breast feeding
  • Subject is not using adequate contraceptive precautions.
  • Other conditions which, in the opinion of the investigator, make participation in an investigational trial of this nature a poor risk
  • Concerns for subject's compliance with the protocol procedures

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

Germany48 sites

  • Research Site

    Aschaffenburg, 63739

  • Research Site

    Augsburg, 86150

  • Research Site

    Berlin, 10367

  • Research Site

    Bonn, 53111

  • Research Site

    Celle, 29223

  • Research Site

    Dresden, 01127

  • Research Site

    Dresden, 01307

  • Research Site

    Erfurt, 99084

  • Research Site

    Flensburg, 24939

  • Research Site

    Frankfurt (Oder), 15236

  • Research Site

    Freiburg im Breisgau, 79110

  • Research Site

    Georgsmarienhütte, 49124

  • Research Site

    Goslar, 38642

  • Research Site

    Göttingen, 37073

  • Research Site

    Halberstadt, 38820

  • Research Site

    Halle, 06110

  • Research Site

    Hanover, 30161

  • Research Site

    Heidelberg, 69120

  • Research Site

    Herne, 44623

  • Research Site

    Hildburghausen, 98646

  • Research Site

    Hildesheim, 31134

  • Research Site

    Kaiserslautern, 67655

  • Research Site

    Kassel, 34119

  • Research Site

    Köthen, 06366

  • Research Site

    Krefeld, 47805

  • Research Site

    Mannheim, 68165

  • Research Site

    Mayen, 56727

  • Research Site

    Moers, 47441

  • Research Site

    Mühlhausen, 99974

  • Research Site

    Mülheim, 45468

  • Research Site

    München, 80639

  • Research Site

    Naunhof, 04683

  • Research Site

    Neunkirchen, 66538

  • Research Site

    Neustadt in Sachsen, 01844

  • Research Site

    Nordhorn, 48527

  • Research Site

    Offenbach, 63069

  • Research Site

    Oldenburg, 26121

  • Research Site

    Ostfildern, 73760

  • Research Site

    Passau, 94036

  • Research Site

    Plauen, 08525

  • Research Site

    Ratingen, 40878

  • Research Site

    Rostock, 18107

  • Research Site

    Singen, 78224

  • Research Site

    Sömmerda, 99610

  • Research Site

    Spremberg, 03130

  • Research Site

    Stolberg, 52222

  • Research Site

    Stralsund, 18435

  • Research Site

    Würselen, 52146

Other trials in Germany

About this study

Official title: A Comparison of Pegfilgrastim (Neulasta®) Application Via Manual Injection Versus Injection Via an On-body Injector Regarding Patient Preference and Health Economics

The study aims to compare two application forms (pre-filled syringe and On-body injector) of the same active drug (pegfilgrastim) in adult patients under chemotherapy regarding patient preference and health economics. Chemotherapy will be supported with pegfilgrastim for four subsequent chemotherapy cycles using alternating application forms.

Read the detailed description

Neutropenia is one of the most common side effects of myelosuppressive chemotherapy. Febrile neutropenia and infectious complications are associated with chemotherapy dose delays and reductions and an increased risk of hospitalization. Prophylaxis with recombinant G-CSFs reduces the incidence, severity and duration of CIN and the risk of developing FN. Pegfilgrastim is available for over 10 years and is specified in the SmPC to be applied at least 24 hours after cytotoxic chemotherapy. For this application patients often have to return to their physician one day after chemotherapy treatment for the sole purpose of receiving pegfilgrastim subcutaneous (s.c.) injection. For different reasons, some of the patients requiring pegfilgrastim may not be able to return at this day and thus may not receive pegfilgrastim in accordance with the SmPC. The On-body injector for pegfilgrastim provides an option for patients not to return to the clinic/medical office the day after chemotherapy for their pegfilgrastim injection. The kit includes a single-use prefilled syringe co-packed with the On-body injector for pegfilgrastim. The On-body injector is applied to the patient's skin at the day of chemotherapy treatment and it automatically delivers pegfilgrastim approximately 27 h after the On-body injector was applied to the patient's skin.

Patient-reported outcomes on preference for either application form can help to guide physicians' treatment choice, particularly in terms of application of the same active substance, in this study pegfilgrastim.

This study aims to compare the two application forms of pegfilgrastim (pegfilgrastim pre-filled syringe vs. On-body injector for pegfilgrastim) with regard to patient preference and health economy. A trial design with randomization of patients to receive the two application forms of pegfilgrastim in an alternating sequence for 4 cycles starting with either On-body injector for pegfilgrastim (Arm A) or pegfilgrastim pre-filled syringe (Arm B) was chosen. In this way, all patients will receive both application forms in order to be able to decide for their individual preference. Four cycles (that means each patient will receive each application form of pegfilgrastim twice) should be a sufficient number for the patient to make a decision. This design with two treatment arms serves to exclude a systematic bias that might be generated when starting with the same application form for all patients.

Being tested
On-body injector, Pre-filled syringe
Keywords
R-CHOP, G-CSF, Early breast cancer, Anthracycline/cyclophosphamide, 1st line, immunochemotherapy, taxane
Medical subject headings
Lymphoma, Non-Hodgkin, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On-body injectorDevice

    Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.

  • Pre-filled syringeDevice

    For subcutaneous injection of a supportive medicine (Pegfilgrastim).

Study groups in NCT03619993
Study groupRoleWhat they receive
Arm A: Start with On-body injectorExperimental4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (OBI-PS-OBI-PS)
Receives: Device: On-body injector; Device: Pre-filled syringe
Arm B: Start with pre-filled syringeExperimental4 consecutive cycles of treatment in total, with 2 cycles of treatment with pegfilgrastim pre-filled syringe (PS) and 2 cycles of treatment with On-body injector (OBI) for pegfilgrastim in an alternating sequence (PS-OBI-PS-OBI)
Receives: Device: On-body injector; Device: Pre-filled syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient preference for type of pegfilgrastim application assessed via project specific survey answered after 4 applications.

    Percentage of patients favoring pegfilgrastim application via On-body injector. Patients are answering the questionnaire after 4 applications of pegfilgrastim in total, with On-body injector and pre-filled syringes used in alternating sequence (each type of application administered two times in total).

    Measured: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

Secondary outcomes (6)

  1. Time point of pegfilgrastim application within a chemotherapy cycle

    The number of hours between chemotherapy application and pegfilgrastim application in each of the 4 observed chemotherapy cycles.

    Measured: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

  2. Patient preference for pegfilgrastim application assessed via project specific survey answered at time of enrollment

    Percentage of patients favoring pegfilgrastim application via On-body injector. Patients are answering the questionnaire before initial application.

    Measured: at enrollment

  3. Impact of type of pegfilgrastim application on daily life of the patient assessed by direct questioning using project specific patient survey.

    Percentage of patients reporting a certain impact level with respect to the type of pegfilgrastim application. Patient questionnaires will be answered after pegfilgrastim application in each of the 4 observed chemotherapy cycles.

    Measured: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

  4. Percentage of nurses favoring pegfilgrastim application via On-body injector at study start and at end of study as stated via a project specific nurse survey

    Percentage of nurses favoring pegfilgrastim application via On-body injector. Nurses are answering the questionnaire at study start and at the end of the study.

    Measured: from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start)

  5. Preference of investigators for either type of pegfilgrastim application at study start und at end of study assessed via project specific investigator survey

    Percentage of investigators favoring pegfilgrastim application via On-body injector. Investigators are answering the questionnaire at study start and at the end of the study.

    Measured: from first enrollment to end of study of last patient at a site (= end of cycle 4 of last patient, expected to be latest 2.5 years after study start)

  6. Cost factors for the health care system for both types of application of pegfilgrastim

    Cost factors are assessed via project specific patient survey addressing time, travel expenses and support needed to receive pegfilgrastim application.

    Measured: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2018
  2. Study start25 Jun 2018
  3. Primary completion10 Sep 2019
  4. Study completion10 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03619993
Sponsor's protocol ID
IOM-040369
Acronym
CONVENIENCE
Status last verified
Dec 2019
First submitted
19 Jun 2018
Last updated
17 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Metz M, Semsek D, Rogmans G, Hutzschenreuter U, Fietz T, Harde J, Zacharias S, Hielscher C, Lorenz A, Zahn MO, Guth D, Liebers S, Berghorn M, Grebhardt S, Matillon CD, Egerer G, Potthoff K. Patient, nurse, and physician preferences: final results of the CONVENIENCE study evaluating pegfilgrastim prophylaxis via pre-filled syringe or on-body injector in cancer patients. Support Care Cancer. 2021 Nov;29(11):6633-6643. doi: 10.1007/s00520-021-06230-9. Epub 2021 May 6.

    PubMed 33956213

Questions about this trial

What is this clinical trial studying?

A study testing On-body injector and Pre-filled syringe in people with Non Hodgkin Lymphoma and Breast Cancer, run by iOMEDICO AG at 48 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient preference for type of pegfilgrastim application assessed via project specific survey answered after 4 applications. (time frame: 4 cycles of chemotherapy, i.e. 8 to 12 weeks (depending on chemotherapeutic regimen)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03619993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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